An interventional study of Overdose Prevention Intervention Package (OPIP) in Overdose Risk, Opioid Use Disorder and Stimulant Use Disorders, sponsored by Michele Staton. Recruiting at 3 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Michele Staton · Not applicable, Interventional, and Prevention
Among 1,222 studies in Opioid-Related Disorders with a site in United States — 246 open to participants now, 316 under way, 20 of them phase 3. Opioid-Related Disorders · United States.
Among the 1,222 studies in Opioid-Related Disorders with a site in United States, this one is the 166th largest by planned enrollment of the 1,097 interventional ones, is one of 84 that started in 2026, is one of 569 with no phase, reaches primary completion later than 311 of the 315 other live ones, and was the 1,142nd registered.
1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's planned enrollment of 300 is above the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →246 of the 1,222 studies in Opioid-Related Disorders with a site in United States are open now, in 7 countries. Each count lists the studies.
Of the 210 Opioid-Related Disorders studies recruiting now, 122 (58%) set no upper age limit and 74 (35%) stop at 75 or younger; 14 take children under 18; 52 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
The full table on the hub →1,222 studies; the count open now beside each. This study's row is marked.
First in 1988; this study’s year is marked. 84 started in 2026.
Median enrollment 56 across the 1,097 interventional studies, 85 across the 122 observational. Of the 833 that completed or were terminated, 331 (40%) have results posted.
132 of 1,222 have an industry lead sponsor. The 10 most frequent:
Michele Staton is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Michele Staton has 3 studies filed under Opioid-Related Disorders — fewer than ten, so there is no comparison to draw.
128 of the studies in Opioid-Related Disorders with a site in United States that are under way reach primary completion within a year, 9 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05011266Phase 3New York State Psychiatric InstituteEfficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder | 2027-01-01 |
| NCT05834478Phase 3Emory UniversityNon-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3 | 2027-02 |
| NCT05033028Phase 3NYU Langone HealthSmartphones for Opiate Addiction Recovery | 2027-06-01 |
| NCT05459402Phase 3University of Maryland, BaltimoreDivided or Single Exposure (DOSE) Study | 2027-06-01 |
| NCT05766631Phase 3Friends Research Institute, Inc.Treating Polysubstance Use Using a Novel Digital Technology | 2027-06-30 |
Among the 1,222 studies in Opioid-Related Disorders with a site in United States, from their registry updates:
This project continues our work with women in the Kentucky Women's Justice Community Overdose Innovation Network Phase II (WJCOIN-II) with the overall aim of reducing overdose risk during the transition from jail to rural communities. WJCOIN-II has potential for significant impact regarding the effectiveness, implementation, and sustainability of innovative overdose prevention strategies during the high-risk time of community re-entry among vulnerable, CLS-involved women in rural communities. This research will impact the field by increasing the capacity of the criminal legal system to respond to the overdose crisis through increased access to prevention strategies to reduce overdose risk.
Overdose deaths among women rose nearly 500% in the past two decades, a rate considerably higher than men. Yet, overdose prevention approaches that target the unique risks of women, particularly those involved in the criminal legal system (CLS) in underserved rural areas, are limited. This application proposes to continue our work with women in the Kentucky Women's Justice Community Overdose Innovation Network Phase II (WJCOIN-II) with the overall aim of reducing overdose risk during the transition from jail to rural communities. Specific aims include: Aim 1: Compare the effectiveness of pre-release RC to RC+SPE in decreasing women's overdose risk during re-entry to rural communities. Through a multi-site 2 X 2 factorial design, women will be randomly assigned to two pre-release conditions (1) Recovery Coaching (RC) only or (2) RC + support person engagement (SPE) to reduce overdose risk through the development of an overdose prevention plan and increase motivation for treatment entry within one-month post-release. Aim 2: Compare the additive effectiveness of CM initiated post-release to RC alone and RC+SPE in decreasing overdose risk and increasing treatment entry and retention among women during re-entry to rural communities. The 2 X 2 factorial randomized design also includes assignment to one of two post-release conditions: 1) continuation of pre-release intervention (RC or RC+SPE) only in the community through ongoing sessions, or 2) addition of contingency management (RC+CM or RC+SPE+CM) to incentivize target behaviors (reduced days of drug use). Depending on treatment entry by the one-month post-release period (non-initiators vs. initiators of treatment), the following aims will be examined post-release from jail: Aim 2a. Among non-initiators, examine the additive effectiveness of post-release CM to reduce overdose risk. Aim 2b. Among treatment initiators, examine the additive effectiveness of post-release CM to increase treatment retention. Aim 3: Contextualize effectiveness of intervention components by examining the roles of perceived acceptability and appropriateness, and identify barriers and facilitators to intervention implementation across the re-entry continuum. Acceptability and appropriateness of intervention components from the perspectives of women and public safety/public health stakeholders (e.g., jail staff, RCs, treatment providers) will be measured through individual-level survey data collection. Aim 4: Examine economic impact of the WJCOIN-II interventions pre-release and post-release in reducing women's overdose risk in rural communities. Cost effectiveness and net societal costs will be assessed by incorporating clinical (overdose risk) and service utilization (treatment entry) outcomes using tailored budget impact tools. The study will make a significant impact regarding the effectiveness, implementation, and sustainability of innovative overdose prevention strategies during the high-risk time of community re-entry among vulnerable, CLS-involved women in rural communities.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Following the clinical assessment, all participants will receive the "base" recovery coaching intervention pre-release. RCs will be employed by VOH and will be women with lived experience with OUD/StUD recovery and CLS involvement who will provide strengths-based, person-centered recovery coaching sessions designed to reduce overdose risk. Women will meet with the RC pre-release to assess basic re-entry needs associated with entering treatment (e.g., lack of housing, food, clothing, transportation, employment). RCs will have access to a "barrier relief fund" to address these needs (e.g., clothes for an interview, transportation vouchers) following established RC protocols. At discharge, all women will be provided re-entry transition kits (e.g., hygiene items, condoms, overdose prevention resources) and naloxone.
Behavioral: Overdose Prevention Intervention Package (OPIP)
Women in this condition will receive the base (RC) pre-release intervention and the Support Person Engagement (SPE) component pre- and post-release. Support Person (SP) designation will draw upon 1) the woman's suggested SP at screening, 2) baseline social network data, and 3) the initial RC meeting. Identified SPs will be screened for eligibility, including being over the age of 18 and willing to engage in intervention sessions. Exclusion criteria for SPs (based on participant and SP self-report) includes past felony conviction, currently incarcerated, on community supervision, or prior history of domestic violence/EPOs. All SPE sessions will align with overdose risk education, understanding treatment options (including MOUD), naloxone distribution, and harm reduction strategies to keep the woman safe during community re-entry. SPs will have access to free naloxone to carry and distribute.
Behavioral: Overdose Prevention Intervention Package (OPIP)
Women randomized to this group will receive the base pre-release RC intervention, 12 weeks of RC meetings post-release, and 12 weeks of CM post-release. Women will be informed before jail release of the expectations in the CM protocol, target behaviors, and incentive opportunities. The WJCOIN-II CM protocol will be an adapted version of Petry and Martin's approach to reinforce three target verifiable behaviors: 1) meeting with the RC; 2) stimulant abstinence; and 3) opioid abstinence using saliva drug screens. At the conclusion of weekly post-release RC sessions, research staff will join the video call for CM. Virtual CM is feasible, acceptable, and comparable to in-person CM, and research staff will administer CM separately to maintain the integrity of the RC/participant rapport. If the participant does not meet with their RC by the last day of a given week, research staff will contact the participant separately for a CM session.
Behavioral: Overdose Prevention Intervention Package (OPIP)
Women in this intervention condition will participate in the RC condition (pre- and post-release), the SPE sessions (pre- and post-release), and CM post-release.
Behavioral: Overdose Prevention Intervention Package (OPIP)
WJCOIN-II's multi-level 2 X 2 randomized factorial design will examine the effectiveness of OPIP components across four study conditions randomly assigned after baseline data collection (n=75 per condition, 100 per jail site), summarized in Table 7 and described below. In addition to group assignment, outcomes will be assessed as a function of engagement in each intervention component defined as the number of sessions attended (RC and CM conditions) and perceived support, which is a count of the number of types of support provided by the RC and SP (e.g., emotional, financial, etc.).
Overdose risk
Overdose risk score based on days of opioid, stimulant, and polysubstance use
Time frame: 3, 6, and 12 months post-release
Treatment entry
Entry into any formal ASAM level of SUD treatment (e.g., outpatient, intensive outpatient, residential, inpatient, MOUD) (yes/no)
Time frame: 1 month postrelease
Plan to share: No — Pending approval by the IRB and NIDA cooperative
Started Jun 2026 (actual). Primary completion is estimated for Oct 2030, 52 months after the start.
Of 464 non-industry interventional studies with no phase under Opioid-Related Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 47. This study's planned 52 months is above that.
Counting every sponsor, half of 495 studies reached it within 29 months; a quarter within 13 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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Michele Staton